PC Triage and Intake Associate

thin them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Let's do this. Let's change the world. In this vital role you will be part of the Global Patient Safety organization this team implements Intake and Triage of product complaints (PCs), adverse events (AEs) and other safety findings (OSFs). Their focus includes assuring compliant processes and systems remain fully compliant through the pharmacovigilance and quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

Job Summary

The PC Triage and Intake Associate is responsible for global triage of Product Complaints and ensure proper Adverse Events and/or Other Safety Findings were captured. Ensure to capture the patient outcome because of the reported event. This position ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes, and procedures.

Key Activities

• Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes.

• Triage of initial data entry (book-in) of new PC, AE and OSF cases is complete.

• Performs the initial book-in activities and appends additional information or documents to the case as they are received in the global intake system.

• Ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes and procedures.

• Supports performance emphasized culture.

• Ensures quality of PC, AE and OSF records.

• Implements Standard Operating Procedure requirements for the triage process.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Education & Experience (Basic)

• Master's degree and 3 years of Drug Safety or Life Sciences experience OR

• Bachelor's degree and 5 years of Drug Safety or Life Sciences experience

Education & Experience (Preferred)

• Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry

• Bachelor's Degree in a health-care subject area or scientific field

• Previous experience with a corporate intake system or safety database

• Ability to successfully manage workload to strict timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

• Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices)

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.
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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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